Dillen Daimy M M, Otsuki Hisao, Takahashi Kuniaki, Kobayashi Yuhei, Piroth Zsolt, Noiseux Nicolas, Nakadi Badih El, Kalinauskas Gintaras, Szekely Laszlo, Davidavičius Giedrius, Teeuwen Koen, Tonino Pim A L, Pijls Nico H J, De Bruyne Bernard, Fearon William F, Zimmermann Frederik M
Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands (D.M.M.D., K. Teeuwen, P.A.L.T., N.H.J.P., F.M.Z.).
Division of Cardiovascular Medicine, Stanford University School of Medicine and Stanford Cardiovascular Institute, Stanford University, CA (H.O., K. Takahashi, W.F.F.).
Circ Cardiovasc Interv. 2025 Jan;18(1):e014610. doi: 10.1161/CIRCINTERVENTIONS.124.014610. Epub 2024 Dec 27.
In the era of first-generation drug-eluting stents and angiography-guided percutaneous coronary intervention (PCI), the presence of a bifurcation lesion was associated with adverse outcomes after PCI. In contrast, the presence of a bifurcation lesion had no impact on outcomes following coronary artery bypass grafting (CABG). Therefore, the presence of a coronary bifurcation lesion requires special attention when choosing between CABG and PCI. The aim of this study is to assess whether the presence of a bifurcation lesion still influences clinical outcomes after contemporary PCI using second-generation drug-eluting stent and fractional flow reserve (FFR) guidance versus CABG.
The randomized FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) compared FFR-guided PCI using current drug-eluting stents with CABG in patients with 3-vessel coronary artery disease. The prespecified key end point at 3-year follow-up was the composite of death, myocardial infarction, or stroke. In this substudy, the impact of bifurcation lesions on outcomes after FFR-guided PCI and CABG was investigated.
The FAME 3 trial enrolled 1500 patients and 653 (45.2%) patients had at least 1 true bifurcation lesion. There was no difference in the composite of death, myocardial infarction, or stroke at the 3-year follow-up between patients with or without at least 1 true bifurcation lesion (11.6% versus 10.0%; hazard ratio, 1.17 [95% CI, 0.86-1.61]; =0.32), regardless of revascularization strategy. The composite end point was not statistically different between FFR-guided PCI and CABG in patients with at least 1 true bifurcation lesion (hazard ratio, 1.27 [95% CI, 0.80-2.00]) or without a true bifurcation lesion (hazard ratio, 1.36 [95% CI, 0.87-2.12]), with no significant interaction (=0.81).
In patients with 3-vessel coronary artery disease, the presence of a true bifurcation lesion was not associated with a different treatment effect after FFR-guided PCI with contemporary drug-eluting stent versus CABG.
在第一代药物洗脱支架和血管造影引导的经皮冠状动脉介入治疗（PCI）时代，分叉病变的存在与PCI术后不良结局相关。相比之下，分叉病变的存在对冠状动脉旁路移植术（CABG）后的结局没有影响。因此，在CABG和PCI之间进行选择时，冠状动脉分叉病变的存在需要特别关注。本研究的目的是评估在使用第二代药物洗脱支架和血流储备分数（FFR）引导的当代PCI与CABG后，分叉病变的存在是否仍会影响临床结局。
随机FAME 3试验（多支血管评估的血流储备分数与血管造影）比较了在三支血管冠状动脉疾病患者中，使用当前药物洗脱支架的FFR引导PCI与CABG。3年随访时预先设定的关键终点是死亡、心肌梗死或中风的复合终点。在这项亚研究中，研究了分叉病变对FFR引导PCI和CABG后结局的影响。
FAME 3试验纳入了1500例患者，653例（45.2%）患者至少有1处真性分叉病变。在有或没有至少1处真性分叉病变的患者中，3年随访时死亡、心肌梗死或中风的复合终点没有差异（11.6%对10.0%；风险比，1.17[95%CI，0.86 - 1.61]；P = 0.32），无论血运重建策略如何。在至少有1处真性分叉病变的患者中，FFR引导PCI和CABG之间的复合终点在统计学上没有差异（风险比，1.27[95%CI，0.80 - 2.00]），在没有真性分叉病变的患者中也是如此（风险比，1.36[95%CI，0.87 - 2.12]），没有显著的交互作用（P = 0.81）。
在三支血管冠状动脉疾病患者中，在使用当代药物洗脱支架的FFR引导PCI与CABG后，真性分叉病变的存在与不同的治疗效果无关。
